Page 295 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q022 SOP Title: RESERCH DATA REQUESTS AT
CHILDREN’S HEALTHsm
• For IRB-approved research projects, the assigned QS member will verify the data elements requested match the IRB-approved protocol data element;.
• Contain data that is verified by the IRB-approved protocol;
• Are for research projects that have obtained IRB approval and
performance site approval (PSA) at Children’s Health.
1. For feasibility requests: assigned QS member needs to verify request is for aggregative/anonymized data.
2. For Preparatory to Research: assigned QS member needs to verify that researcher has signed The Preparatory to Research Attestation statement prior to any data release that includes PHI.
3. Children’s Health Research Administration will not approve data requests when those requests:
• Are not submitted through the approved data analytics process;
• Are without review by the QS team to confirm data being requested
is IRB approved;
• Are for research projects that have not obtained IRB approval and
performance site approval (PSA) at Children’s Health.
4. RESPONSIBILITIES
4.1 CHRA Quality Specialist
For IRB-approved studies:
1. During performance site review, assigned QS member will verify whether the researcher will require CMC AA data extraction services.
2. For those requiring AA services, QS will guide members of the study team (PI, PRC, PAC) to submit a data request to: https://dallaschildrens.sharepoint.com/teams/dig/request /Lists/Research%20 Requests//EditForm.aspx
3. An email notification will be received in the Research-DataRequest mailbox managed by the Quality Specialists. The subject line will reflect:
“Research request #___ submitted [short title: either (Feasibility); or (Preparatory to Research); or (Advanced Analytics Research Request); or (Self Data Pull Request)]”.
4. When the email is received, QS will open the data request work queue at: https://dallasc hildre ns. sh arep oint .c om /team s/d ig/r equ est /SiteP age s/Re searc h%20Work%20Queue.aspx and review each request.
SOP#23: 04/14/2020; 06/10/2020; 11/08/2020; 08/25/2021